The FDA Re-Org Has Begun. What Does it Mean for You?

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief

BACKGROUND:

The FDA began a plan to align the Office of Regulatory Affairs (ORA) into a ‘program based structure’ in 2013.  This reorganization is now being implemented. The ORA is the lead for all FDA field activities including inspections of regulated products and their manufacturers, and review of imported products.  Effective May 15, 2017, we enter the transition phase as the FDA moves to reorganize the ORA structure and function to align with the agency’s centers. The FDA provides information on each of the areas, including a ‘fact sheet’ and a ‘boundary map’ for these offices.

This refined organization represents more of a ‘commodity based’ and ‘vertically integrated’ organization rather than one with a focus on geographic structure.  Employees now will work in a particular commodity area rather than having responsibilities in multiple areas.  These changes are driven by the need to keep pace with ongoing public health concerns and the increasingly complex science that serves as the basis for innovative medical and device products.  Thus, staff will specialize in a particular area rather than have broad ranging responsibilities in multiple product areas.  When I lived in San Diego years ago, an investigator would perform inspections of a seafood site on Monday and a device manufacturer on Thursday.  It is challenging and perhaps unrealistic to expect individual investigators to maintain expertise in the diverse areas of food, devices, drugs, and biologics.

WHAT DOES THIS MEAN FOR THE INDUSTRY:

For those of us who remember, this is reminiscent of the development and implementation of Team Biologics whose members were intended to have deep expertise in the Biologics area including recombinant DNA products and monoclonal antibodies. History does repeat itself though this represents a much broader expansion of this expertise focus.

For the regulated industries governed by the FDA, this should mean that investigators will be better educated in the product type(s) they evaluate.  We can expect them to have a better understanding of the underlying science and technologies that enable these products.  The investigators should be working more closely with product reviewers and we should expect that inspections will include additional follow-up items identified by the product reviewers if they do not participate in the inspections themselves.  And now with investigators trained in the science supporting these products, they will be more effective in their evaluation and follow-up of issues raised during the product review.

None of this will happen over-night and will remain a work in progress for years to come.  It is unclear how recently proposed budget cuts will impact implementation of this and other FDA programs.  The focus on product specialization will hopefully be a lasting feature of the FDA inspection programs and should serve both the industry and the agency’s goals.  Time and funding will tell, and, even under the best of circumstances, this will take years to reach fruition.

SUMMARY OF REORGANIZATION:

This reorganization is divided into seven program areas, not including the laboratories, as below:

  1. Office of BioResearch Monitoring Operations (OBIMO)
  2. Office of Biological Products Operations (OBPO)
  3. Office of Medical Device and Radiological Health Operations
  4. Office of Pharmaceutical Quality Operations (OPQ)
  5. Office of Human and Animal Food Operations (OHAFO)
  6. Office of Enforcement and Import Operations (OEIO)
  7. Tobacco Operations Program

The Office of Regulatory Science, including the Laboratories, is also being reorganized with product area focus.  With the exception of the Tobacco Operations Program, the other six offices above are now divided into regional divisions that include the twenty existing districts and thirteen field laboratories.  We address each of these eight areas in turn.

The office staff are responsible for serving on relevant inter-agency programs and initiatives.  In addition, some product types may require the input and expertise from individuals in more than one center and the new organization should facilitate that interaction.

  1. Office of BioResearch Monitoring Operations (OBIMO)

This office focuses its efforts in the areas of Good Clinical Practice and Good Laboratory Practice (21CFR58).  This office ‘…ensures the quality and integrity of data in clinical and non-clinical studies…’ provided in support of applications for products related by all FDA Centers.  Activities include inspections of clinical and non-clinical research sites in support of these applications.  Note that while their responsibilities include data integrity for clinical and non-clinical studies, this topic is not limited to the manufacture and testing of medicinal products.

The new office is divided into two regional divisions.  Region 1 includes Puerto Rico and all areas including and east of the New Orleans District and the Cincinnati District.  Region 2 includes Alaska, Hawaii, and those areas west of the New Orleans District and the Cincinnati District.

  1. Office of Biological Product Operations (OBPO)

This office manages the compliance activities for blood and tissues products, vaccines, and other biological products regulated by CBER.  Among the innovative products in this area are the CAR T-cell products, several of which are currently under review.

The new office is divided into the same two division as the BIMO office above.

  1. Office of Medical Device and Radiological Health Operations (OMDRHO)

This office is responsible for inspections of devices and radiation-emitting products.  Devices constitute a broad range of products from band-aids to implantable devices such as knee replacements to drug-eluting coronary stents.

This office is divided into three divisions, likely based on the number and variety of different products for which they provide oversight.  Division 1 includes the northeast sector of the US, all areas including and northeast of the Detroit, Cincinnati, and Baltimore Districts.  Division 2 includes the middle of the country and the southeast.  Division 3 includes The Seattle, Denver and New Orleans Districts and all areas west of those including Alaska and Hawaii.

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  1. Office of Pharmaceutical Quality Operations (OPQO)

This group has responsibility for inspection and investigations of pharmaceutical sites, including those that manufacture recombinant DNA products and monoclonal antibodies.  This office will primarily work with staff in CDER and CVM.

The office includes a Division of Pharmaceutical Quality Programs and a Division of Foreign Pharmaceutical Quality Inspections.  Four additional divisions are divided among the New England, Puerto Rico/mid-Atlantic area, the upper Midwest/Texas/southeastern US, and the western US including Alaska and Hawaii.

  1. Office of Human and Animal Food Operations (OHAFO)

This office provides field inspections and compliance operations for all activities related to both human and animal food products.  In performing these responsibilities, they will coordinate with CVM and CFSAN.  Significant efforts will apply to the continued implementation of the Food Safety Modernization Act.

This office is divided into two major divisions, East and West.  Within each of these major groups are six subgroups each.  Puerto Rico is in the eastern division and Alaska and Hawaii are within the West.

  1. Office of Enforcement and Import Operations (OEIO)

This office provides oversight of field import operations and is the point of contact for all import programs for FDA-regulated products.  This office will work with law enforcement authorities as necessary to complete their work.

This office includes five divisions, again largely divided on geographic boundaries:  The Northern Border Import Area extends across the entire border between the US and Canada; the Northeast Import area includes New England and selected mid-Atlantic states; the Southeast Import area includes the southeast states; the Southwest import states include some of the great plains states and the southwest; and finally, the West Coast Import area makes up the rest along with Hawaii.  Interestingly for this one, both Puerto Rico and Alaska (yes, Alaska) are included in the Southeast Import Division.

  1. Tobacco Operations Program

This office ensures that the tobacco industry follows the laws and regulations governing their industry.  The office does not have any divisions and its enforcement is supported by the Center for Tobacco Products (CTP).  They particularly focus with CTP on the implementation of the Family Smoking Prevention and Tobacco Control Act.

The Office of Regulatory Science supports the Lab Optimization initiative from 2009 to address issues across the 14 laboratories throughout the US and Puerto Rico.    Laboratories focus on testing for the following areas:  human and animal foods (5), Medical Products (3), HAF and MPT (3), specialty labs (2), and an ORA screening station (1).

CONCLUSION:

In summary, the FDA has reorganized ORA on a commodity, rather than geographic, basis to better align with other offices within FDA.  This should result in investigators with deep expertise in their product area(s) rather than covering all types of inspections for products governed by FDA.  This is a work in progress that we will follow as it is implemented.  A serious question remains about the FDA’s funding under the new administration and if/how that will impact this refinement.  Even under the best of funding circumstances, this is a significant change that will take years to fully implement.

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence. Contact me if you ever have questions at tony@fdazilla.com.

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